欧盟批准Gilead的Trodelvy联合Keytruda一线治疗PD-L1阳性转移性三阴乳腺癌

Gilead Sciences (GILD) said Monday that the European Commission has approved Trodelvy in combination with Merck’s (MRK) Keytruda as a first-line treatment for adults with PD-L1-positive, unresectable, locally advanced, or metastatic triple-negative breast cancer.
Trodelvy plus Keytruda is the first and only antibody-drug conjugate plus immunotherapy combination to be approved in first-line metastatic TNBC in the European Union’s 27 member states, as well asNorway,IcelandandLiechtenstein, the company said.
This decision follows the recent EC approval of Trodelvy as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy.
Together, these approvals establish Trodelvy as the backbone therapy for patients with first-line metastatic TNBC across PD-L1 status inEurope. This decision provides a new treatment option for the most aggressive form of breast cancer at the first sign of metastatic disease.
“The approval of Trodelvy plus Keytruda represents a meaningful advance in the treatment of patients with PD-L1-positive metastatic TNBC,” saidEvandro de Azambuja, MD, PhD, Head of the Medical Support Team, Jules Bordet Institute, and investigator of the ASCENT-04 study.